Introduction:
Affiliated Hospital of North Sichuan Medical College obtained the NMPA certification for drug clinical trial institutions in October 2019 (Certificate Number 1182), covering multiple specialties. In 2020, the institution completed NMPA official website registration in line with the latest "Regulations for Quality Management of Drug Clinical Trials." Leaders of the hospital and responsible individuals in the institution attach great importance to clinical trial work and provide strong support. The institution has facilities including offices, quality control rooms, central pharmacies, archives rooms, meeting rooms, reception rooms, etc. The institution has a well-established management process, taking responsibility for project review, operation, funding, data management, quality assurance, and other aspects of drug/medical device clinical trials. Project application forms and other trial-related documents are accessible on the hospital's official website. Clinical department has highly skilled medical professionals, top-notch equipment, and an abundant source of diseases. The research team regularly receives training in knowledge and skills related to clinical trials. We have always maintained a rigorous scientific attitude, using professional researchers, scientific trial design, standardized operating procedures, and strict management systems to conscientiously complete each clinical trial, ensuring the safety of the trial subjects. We sincerely welcome domestic and foreign pharmaceutical companies and contract research organizations to collaborate extensively with our institution in the field of clinical trials. This collaboration aims to contribute to the sustained development of clinical trials in China and the improvement of the health of the general population. |
The Ethics Committee for Drug Clinical Trials is part of the Affiliated Hospital of North Sichuan Medical College and was established in March 2018. Comprising 13 members, it includes professionals from medical and non-medical fields, legal experts, and individuals external to research/trial units. Additionally, there is a full-time secretary.
The committee operates from an independent office with well-equipped archives, providing the necessary facilities for ethical reviews. The Ethics Committee has established a comprehensive system for the review of drug clinical trials, ethical review application guidelines, and SOPs. It has also implemented an initial training and continuous education mechanism, ensuring that all ethics committee members undergo training in GCP, ethical review, and relevant regulatory knowledge to meet the GCP standards for review capability.
Objective: The committee aims to safeguard the dignity, safety, and rights of participants by scrutinizing the scientific and ethical dimensions of clinical research projects. It strives to elevate biomedical research to rigorous scientific and ethical standards, fostering increased public trust and support for clinical research.
Working Basis: The committee adheres to established guidelines such as the "Guiding Principles for Ethical Review of Drug Clinical Trials," "Regulations for Quality Management of Drug Clinical Trials," "Helsinki Declaration," and "Ethical Review Methods for Biomedical Research Involving Humans."
Responsibilities: The committee fulfills its duty to protect the safety and rights of participants by conducting independent, fair, and timely reviews of the ethical aspects of drug clinical trial projects submitted by applicants.